Disclosing Harm

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Physician speaking to patient and loved ones at bedside
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Professional obligations also extend to “no harm” and “near miss” incidents

A 12-year old girl attends with her mother at her pediatrician’s office to get the meningococcal vaccine. Instead, the girl accidentally receives an HPV vaccine. Given that the girl is not likely to experience harm in receiving the vaccine, does the doctor need to tell the family about the mix-up?

The answer, according to a recently approved College policy, is a resounding yes.

While it is generally understood that all incidents that have resulted in harm to a patient must be disclosed, physicians also need to know that professional obligations also extend to “no-harm” and “near miss” incidents, which are defined in the College’s Disclosure of Harm policy in accordance with internationally-accepted terminology on patient safety.

The policy describes a “no-harm” incident, such as the vaccine incident above, as a situation “where the potential for harm has reached the patient, even though the patient has not experienced any immediate, discernible, or clinically apparent harmful effects.”

The reason for disclosure is that harm might manifest in the future. “Where a potentially harmful incident has reached a patient, there must be certainty about whether harm has occurred, and this certainty can only be achieved by discussing the incident with the patient,” states the accompanying Advice to the Profession document. Acknowledgment of the incident will also allow the patient, family, and health-care team to monitor and potentially intervene to prevent potential future harm. In this particular case, informing the patient’s mother would alert her to the need to ensure her daughter receives a vaccine for meningitis.

In considering what kinds of incidents must be disclosed, the advice document reminds physicians that the purpose of disclosure is not to attribute blame. Rather, disclosure aims to provide patients with a full understanding of all aspects of their health care, as well as the information they need to make autonomous, informed medical decisions. Moreover, disclosure may be necessary to the informed consent process to ensure that the patient can make fully informed decisions with respect to any subsequent treatment.

The policy also addresses “a near miss incident,” also known as a “close call.” These are potentially harmful incidents that did not reach the patient due to timely intervention or good fortune. An example is issuing the wrong unit of blood to a patient, but detecting the error before the infusion began.

Physicians must consider whether a near miss needs to be disclosed to the patient, using their professional judgment and taking into account whether:

A. The patient is aware of the incident and an explanation will reduce concern and promote trust; 
B. The patient should be educated to monitor for future similar incidents; and 
C. A reasonable person in the patient’s position would want to know about the incident.

The advice document acknowledges that physicians may struggle to find the support they need in disclosing incidents to patients and their families, including how to apologize when something has gone wrong, and provides guidance about how to conduct these discussions effectively. For example, the most effective apologies demonstrate sincerity, empathy, and genuine concern for the patient’s well-being, and apologies should therefore be tailored in each individual circumstance, avoiding a formulaic approach. The advice document provides more tips and guidance that may be helpful in thinking about disclosure and apologies.

For more information about the policy please go to the College’s website.